Posted on
Tuesday 23 July 2013

Sir Andrew Witty is preparing to admit failings following bribery allegations against GSK

Daily Telegraph

By Denise Roland

20 Jul 2013

Britain’s biggest drug maker did not know it was under criminal investigation in China until police stormed its Shanghai offices in late June. When news filtered back to London, executives were non-plussed and scrambled to try to get details of what was going on. Now there is little doubt GlaxoSmithKline is embroiled in one of the biggest criminal inquiries into bribery ever conducted in China and its executives in the UK capital are poring over the details. Like any approaching tidal wave, it started with just a few ripples. The first came in February, when Chinese authorities called around the world’s drug giants demanding information about their pricing practices in the country. At the same time, GSK was dealing with a separate investigation prompted by whistle-blower claims that sales executives were plying Chinese doctors with extravagant gifts in return for prescribing its products.

GSK was confident the allegations were unfounded. When they became public in June, it issued a statement revealing the “significant resources” it had used to “thoroughly investigate” the claims. “GSK wants to reiterate to its patients, staff and partners in China that these allegations are false,” it declared. It wasn’t long before events took a darker turn. Shortly after the raid on GSK’s China headquarters, a statement came from authorities in the regional city of Changsha announcing that certain individuals were under investigation for “economic crimes”. Since then, four of GSK’s senior executives have been arrested by Chinese police without formal charges. Several more are under house arrest, and one British executive is forbidden from leaving the country.

One of the detainees was paraded on state television last week to make a public “confession” to bribery. The other three have allegedly admitted to corrupt practices during police questioning. At the same time, a chilling message delivered by Beijing’s top official for economic crime, Gao Feng, left the rest of the industry in no doubt that they too could face the same treatment. “Frankly speaking, from our investigation we have also found some clues of illegal money transfers involving other foreign companies. Whether they have been involved in these allegations we are not so sure now. Probably you better ask them yourself. One question is enough: Can you sleep well at night?”…

This is yet to be seen, but the accusations have been spelled out by the Chinese authorities. GSK sales representatives have allegedly paid out up to 3bn renminbi (£320m) in bribes to every level of the Chinese healthcare system using the country’s network of 700 so-called travel agents, the local term for conference organisers. The practice, say the police, has won the company more sales, clinched higher prices, and has been going on since 2007. The accusations go further still: GSK staff are alleged to have accepted bribes and even sexual favours from travel agents desperate for the financial rewards associated with facilitating the illicit payments.

GSK is on red alert. It has dispatched its head of emerging markets with a team of internal auditors and lawyers to the country to carry out an investigation. The evidence uncovered so far appears to give some support to the allegations. Ernst & Young has also been hired to conduct an independent inquiry. The Daily Telegraph disclosed yesterday that Sir Andrew Witty, the chief executive, is preparing to admit to major compliance failings in China when he faces investors this week at its second-quarter update. He also plans to travel to China to repair relations and try to support the state’s attempts to clean up the drug market…

It’s hard to ignore the evidence that the GSK people keep leaving in their wake. In fact, it seems to be something of an industry-wide standard – a corrupted marketing underbelly that pervades pharmaceutica. BMJ Editor Fiona Godlee said "that the pharmaceutical industry has an irreducible conflict of interest in relation to the way it represents its drugs, in science and in marketing" [a sticky wicket…]. She was talking about Clinical Trials in the specific, but that comment can easily be generalized to many, if not most, of their marketing activities. It’s reminiscent of the recent mortgage crisis where home mortgages became a commodity in their own right, disembodied from their true meaning – an inevitable collapse waiting to happen as their artificially inflated prices outran their value by leaps and bounds. Robert Shiller used the term financial bubble and borrowed Alan Greenspan’s phrase, "irrational exuberance" to describe the process in the mortgage markets. We’ve certainly seen a lot of that in the psycho·pharmaceuticals with exaggerated efficacy and minimized or hidden side effect profiles.

But this news from China is step along an even darker road – bribery up and down the healthcare chain. Not that industry manipulation of Clinical Trial Reports, off-label promotion of drugs, jury-rigged Continuing Medical Education programs, or purchased favors from academic medicine are any more acceptable, but if these reports pan out, they have a Tony Soprano feel that even the most jaded among us didn’t expect. This isn’t even white collar crime. It’s just crime, the kind that’s impervious to spin or even carefully worded legalese. Apparently, they’ll do whatever they think they can get away with to increase their profit margin. With China on the front page, Sir Andrew Witty is not going to convince any of us that his campaign to clean up his brand’s reputation is anything more than smoke and mirrors.

At some point, we’re going to have to face up to the wisdom of Dr. Godlee’s simple words – "an irreducible conflict of interest." Fingers in the Dyke can never actually rise to the task. Pharmaceutical companies can’t be expected to maintain the expensive research laboratories required for drug development with low rates of success, play it straight with the drugs they’re able to get through the regulatory hoops, and sell them at a reasonable price for only the approved indications, while profiting only for the drug’s patent life. The industry thrives by relying on irrational exuberance, well designed illusion, and a dash or two of crime. And they can’t seem to stop…

The pharmaceutical industry has "mobilised" an army of patient groups to lobby against plans to force companies to publish secret documents on drugs trials. Drugs companies publish only a fraction of their results and keep much of the information to themselves, but regulators want to ban the practice. If companies published all of their clinical trials data, independent scientists could reanalyse their results and check companies’ claims about the safety and efficacy of drugs. Under proposals being thrashed out in Europe, drugs companies would be compelled to release all of their data, including results that show drugs do not work or cause dangerous side-effects.

While some companies have agreed to share data more freely, the industry has broadly resisted the moves. The latest strategy shows how patient groups – many of which receive some or all of their funding from drugs companies – have been brought into the battle. The strategy was drawn up by two large trade groups, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), and outlined in a memo to senior industry figures this month, according to an email seen by the Guardian.

The memo, from Richard Bergström, director general of EFPIA, went to directors and legal counsel at Roche, Merck, Pfizer, GSK, AstraZeneca, Eli Lilly, Novartis and many smaller companies. It was leaked by a drugs company employee. The email describes a four-pronged campaign that starts with "mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data". Translated, that means patient groups go into bat for the industry by raising fears that if full results from drug trials are published, the information might be misinterpreted and cause a health scare. The lobbying is targeted at Europe where the European Medicines Agency (EMA) wants to publish all of the clinical study reports that companies have filed, and where negotiations around the clinical trials directive could force drug companies to publish all clinical trial results in a public database…

The charges in China are a surprise only because supposedly Chinese regulation is more lax than in the West. GSK has been lying and cheating all over the world to sell drugs. Every time they get caught, it’s a big show of innocence.

HIs company, for whom he is spokesperson, has caused untold misery to Paxil/Seroxat sufferers and despite Witty’s 3 bn. fine in the US, he keeps on going, he keeps on going – one disaster after another and if, all Witty’s plaintiff cries of ‘we are innocent of wrongdoing, we make people feel better and live longer’ had an ounce of credibility’ then he would deserve his knighthood.

This man has tried to bury study Paxil 329 and it’s time his time is up….
and not with a golden handshake either, with a prison sentence…..

Welcome home, Mickey, hope you had a lovely vacation. The weather in Scotland is 32 degrees C and counting…….I am thankful to have survived the usual Seroxat story…but, surely it’s time that the ‘powers that be’ whoever they are, took a long hard look at the way GSK behave……..Fiona Godlee must speak up and Ben and David Healy and 1BOM….let’s all speak up…….

Department of Sociology, New York University, New York, NY 10012, USA. owen.whooley@nyu.edu
Abstract

In 1980 the American Psychiatric Association (APA), faced with increased professional competition, revised the Diagnostic and Statistical Manual of Mental Disorders (DSM). Psychiatric expertise was redefined along a biomedical model via a standardised nosology. While they were an integral part of capturing professional authority, the revisions demystified psychiatric expertise, leaving psychiatrists vulnerable to infringements upon their autonomy by institutions adopting the DSM literally. This research explores the tensions surrounding standardisation in psychiatry. Drawing on in-depth interviews with psychiatrists, I explore the ‘sociological ambivalence’ psychiatrists feel towards the DSM, which arises from the tension between the desire for autonomy in practice and the professional goal of legitimacy within the system of mental health professions. To carve a space for autonomy for their practice, psychiatrists develop ‘workarounds’ that undermine the DSM in practice. These workarounds include employing alternative diagnostic typologies, fudging the numbers (or codes) on official paperwork and negotiating diagnoses with patients. In creating opportunities for patient input and resistance to fixed diagnoses, the varied use of the DSM raises fundamental questions for psychiatrists about the role of the biomedical model of mental illness, especially its particular manifestation in the DSM.

Back so soon, or using technology while enjoying northern territories? GSK has nothing on the duration and depth of what Lilly had done for decades, they just own the state of Indiana to hide it better.

And we as a culture aid and abet the behaviors, clamoring for more chemical fixes. Had a patient recently try to convince me to support his efforts to rationalize cannabis needs to be given to him. Oops, maryland has not legalized pot nor labeled it a medical necessity, yet.

Wait til illicits get a foothold in the legitimate marketplace, you ain’t seen nuttin’ yet in what Lillys and GSKs will do to cash in!

I read the link you provided above, and can only say this, the antipsychiatry dogma of meds are bad for all is nice in theory, but what do you offer for patients who have features of schizophrenia and are not offered care?

Frankly, while you personally may not fit this comment, I think the bulk of antipsychiatry writers if not outwardly, at least covertly really want to abandon people with psychological struggles that won’t go away with “time” or “put on the boots and walk it off”.

Because if antipsychiatry believers really do care and have a concern for the well being of people struggling with symptoms and signs of genuine mental illness, you offer alternatives of significant impact and duration to help.

I have yet to really read anything of substance from most of you who just bash meds for the sake of telling us meds are bad irregardless of drug, dose, and duration of use. You as a group have a perspective, but not the only voice in the debate. Frankly, the way some carry on a sites like this, it really does reinforce my opinion about what really drives this crusade to eradicate psychiatry and anything it supports is akin to what drives extremist Islamic attitudes to Western culture.

Oh really Joel, that’s all you have to offer up after all the years of bloviating bravado.

“I think the bulk of antipsychiatry writers if not outwardly, at least covertly really want to abandon people with psychological struggles that won’t go away with “time” or “put on the boots and walk it off”.

Should everyone assume you are referring too and attacking those dangerous “anti-psychiatry” folks who are deeply & genuinely concerned about the overuse of ineffective & dangerous drugs/devices, those good heart-ed zealots of truth who are voicing concerns about the overuse & misuse of these much overly touted drugs, or those past victims or family members speaking out against the now intrinsic disease of medical profiteering & misinformation pandering entrenched in your floundering & waning profession.

Or are you just referring to those “anti-psychiatry’ folks who are pulling back the curtain of the evidenced shoddy science, the confirmed corrupt research; those pesky “anti-psychiatry” folks who stand up against today’s ongoing medical professions condoned acts of patient abuse, the lack of informed consent, denial of basic human rights, and the lacking of actual unbiased community support & resources that could lead to much better long term results, outcome, and prolonged recovery.

I’m sure you must be also referring to those “anti-psychiatry” folks who are committed without any compensation unlike yourself; to confronting the catastrophic personal & societal consequences of this deeply corrupted and unscientific bio-medical psychiatric model that has dominated our culture for far to long.

Hey, Jamzo— I’ve been doing some reading on the Roger Blashfield website you linked to. Also bought Of Two Minds by T.M. Lurhmann, and though I am not finished with her book yet, it gives me the feeling that bio-bio-bio psychiatry took over and forgot all other aspects of human psychology in a very short time.

I don’t ‘run with a pack’. I am insulted at being generalized into a group you have judged without personally knowing and calling them fuel-filled names. That being said, I have witnessed suffering beyond what most people have in the psychiatric world. This is a sad reality: the meds don’t work, there are no answers, no cures, no “magic bullet”. With that said, I should make sure and remind you I feel everyone’s pain, empathize and wish I DID have an answer. I AM open-minded and willing and DO listen to those who ‘have made it’ and have a story to tell! Lord have mercy! As a doctor you must feel frustrated only having 1 thing to offer the patient in a 15 minute med check appt. Besides all of the billing issues? right?

Again, to Stephany, did you read what I wrote, let me put it in capitals to refresh your not completely attentive read of my comment:

“FRANKLY, WHILE YOU PERSONALLY MAY NOT FIT THIS COMMENT,…” as the comment was addressed to you. And what is fascinating when I write a comment about antipsychiatrists, often the very people I am addressing, without saying any specific names or aliases mind you, do not disappoint in their quick, terse, and even more insulting retorts, until proven otherwise.

Which is what extremists do, maybe I am out of line equating antipsychiatry with Islamic extremists, but, it gets attention, eh?

So, I am printing this comment and then going to your last link re madinamerica. At least I make the time to read the links.

Again, rejecting the average behaviors of psychiatrists of the past 10 or more years has SOME validity, but, the dissenters as a whole want complete genuflection to the point of view. That is not debate, that is frank control, and in the end, equal but opposite to the very behaviors antipsychiatry criticizes and excoriates, yet mirrors the very antagonists and thus deflects opportunity to be respectfully heard.

Again, NOT YOU SPECIFICALLY STEPHANY, but I suggest to those who are unhappy with psychiatry as a whole, tone down the rhetoric and offer alternative interventions.

Oh, and it was poor choice for an advocacy group to invite this rhetoric to a group who will look for any alleged validation to be non compliant. But, until proven otherwise, is that the agenda of Antipsychiatry? I am not hearing otherwise from sources that are unbiased and objective.

Oh, and by the way, using Whitaker to reject Torrey is like using Stalin to reject Hitler. Extreme and rigid examples of people who are about agenda first, and the needs of the public second at the very best.

Where is the middle ground to mental health care interventions, folks?

OK got it Dr Hassman— middle ground? there really is nothing else to offer people— isn’t that awful and I mean awful when I write it! There are great ideas with a few working models like Soteria Houses, but so few of them that it isn’t a viable option for people to use to either live off of meds or remove meds if they want to; it’s extreme options only, meds and or hospitalizations and that becomes the all-around revolving door of care–America, is a corporate nation, the drug companies run the show with there hand out to the almighty dollar–doctors are paid by the industry to promote their pills not care–and sadly until there is funding for alternative care/boarding/hospitals that do not make medication mandatory there will be nothing else left to offer but this same ol’ S*hit. Excuse my french!

Dr. Hassman, with all due respect, advocating a minimal harm approach regarding prescribing antipsychotics is not anti psychiatry as Whitaker has done. Personally, I would think you or any psychiatrist would be interested in prescribing as little medication as possible to help your patients even if it is necessary. Isn’t that the middle ground you should be striving for?

You also might want to google Will Hall, a therapist with schizophrenia who doesn’t take medication and discusses non med alternatives. He is pro choice regarding medication even though he chooses not to take it.

Respectfully, I disagree, there are plenty of options if people honestly and genuinely believe there is a place for mental health care, as there is real and quantifiable pain and anguish in psychological distress. But, there are writers who frequent blogs like this one who are only interested in the demise and utter obliteration of not only psychiatry, but mental health care as a whole.

The rhetoric to this interpretation is easily concluded by readers who are interested in debate and dialogue. Yeah, too many in my field are now not only too quick to grab an RX pad, but even those who don’t have the ability to write scripts just force the blinders onto naive and unsuspecting patients to accept the mentality. The main reason why I am leaving my current job, and just going back to Locum work, to not be tied down for long periods of time to a place and culture that dooms opportunity.

So, to quote an Alan Parsons song I truly love,

“It’s no good believing in somebody else
If you can’t believe in yourself
You give them the reason to take all the power and wealth
It’s no good you trying to sit on the fence
And hope that the trouble will pass
‘Cause sittin’ on fences can make you a pain in the ass

If there’s something you find to believe in
Then the message must get through
So don’t just sit in silence
When you know what to do
Turn it up
Turn it up, make it louder
Turn it up
Turn it up, make it louder

There’s no conversation if nobody speaks
And nothing gets done in the end
There’s no confrontation when fantasy makes you its friend
So much injustice, too many lies
We don’t have to look very far
But nothing will change if we leave things the way that they are

If there’s something you find to believe in
Then the message must get through
So don’t just sit in silence
When you know what to do
Turn it up
Turn it up, make it louder
Turn it up”

But, if you blast it and don’t allow people to digest the point, you are not a spokesperson, but just extremely loud white noise.

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains

1. (1) data through intervention or interaction with the individual, or
2. identifiable private information.

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

Institution is defined in 45 CFR 46.102(b) as any public or private entity or agency (including federal, state, and other agencies).

For purposes of this document, an institution’s employees or agents refers to individuals who: (1) act on behalf of the institution; (2) exercise institutional authority or responsibility; or (3) perform institutionally designated activities. “Employees and agents” can include staff, students, contractors, and volunteers, among others, regardless of whether the individual is receiving compensation.”http://www.hhs.gov/ohrp/policy/engage08.html

Tom, we wanted to welcome Mickey back big time. All jokes aside, it is interesting how everyone’s version of the middle ground is different.

On Pete Early’s blog, because I expressed grave concerns about involuntary commitment, someone essentially said I was too radical. For obvious reasons, I will keep my opinions about that to myself but let’s just say they weren’t positive.

I think the fact this discussion is taking place is a good thing no matter what your opinion is of meds vs. no meds as I think everyone would agree the current system has alot of failures.